The Evaluation of an Alternative Sizing Model in Comparison of a Conventional Sizing Model for Full Face Masks in the Treatment of OSA in Terms of Performance and Comfort

NCT02851628 | Completed DMC

• 1 other identifier: CIA-194
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 4

Brief Summary

The investigation is a prospective non-blinded and semi-randomized clinical investigation. The investigation is designed to assess the alternative sizing model which the trial mask concept is based on and how it compares to a conventional sizing present in the Prototype Full Face Mask (PFFM) mask.

Conditions

Sleep Disordered Breathing; Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (3)

• Seal Comfort

  Obtained from subjective questionnaire

  Up to 3 weeks in-home

• Subjective Seal Leak

  Obtained from subjective questionnaire

  Up to 3 weeks in-home

• Objective Seal Leak

  Measured by device data

  Up to 3 weeks in-home

Secondary Outcomes (2)

• Objective correct mask selection

  Up to 3 weeks in-home

• Subjective correct mask selection

  Up to 3 weeks in-home

Study Arms (2)

Alternative sizing model trial mask

EXPERIMENTAL

In this arm participants who are randomized to the alternative sizing model based mask will be given the alternative sizing model based mask to use in home for the duration of this arm.

Device: Alternative sizing model based trial mask

Prototype Full Face Mask (PFFM)

ACTIVE COMPARATOR

In this arm, participants who are randomized to the PFFM will be given the PFFM to use in-home for the duration of this arm.

Device: Prototype Full Face Mask

Interventions

Alternative sizing model based trial mask DEVICE

A trial full face mask to be used for this trial for the treatment of obstructive sleep apnea using CPAP therapy.

Alternative sizing model trial mask

Prototype Full Face Mask DEVICE

A prototype full face mask with previous clinical trial experience used for the treatment of obstructive sleep apnea using CPAP therapy.

Prototype Full Face Mask (PFFM)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult (18+ years of age)
• Able to give consent
• Apnea Hypopnea Index (AHI) ≥ 5 on diagnostic night
• Prescribed a Continuous Positive Airway Pressure (CPAP) device after successful OSA diagnosis
• Existing nasal or full face mask user.

You may not qualify if:

• Inability to give consent
• Patients who are in a coma or a decreased level of consciousness.
• Anatomical or physiological conditions making APAP therapy inappropriate (e.g. unconsolidated facial structure)
• Commercial drivers who are investigated by New Zealand Transport Agency (NZTA)
• Current diagnosis of CO2 retention
• Pregnant or may think they are pregnant.

Sponsors & Collaborators

• Fisher and Paykel Healthcare: lead

Study Sites (4)

Hastings Memorial Hospital

Hastings, Hawkes Bay, 1420, New Zealand

Location

Waikato Hospital (Waikato DHB)

Hamilton, Waikato Region, 3204, New Zealand

Location

Fisher & Paykel Healthcare

Auckland, 2013, New Zealand

Location

Bowen Hospital

Wellington, 6035, New Zealand

Location

MeSH Terms

Conditions

Sleep Apnea Syndromes; Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Kayan Gonda, BSc

  Sponsor Employee

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2016
• First Posted: August 1, 2016
• Study Start: September 11, 2017
• Primary Completion: November 3, 2017
• Study Completion: December 20, 2017
• Last Updated: April 18, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

NZ (4)